OXCARBAZEPINE (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Bottle Label

NDC 60429-061-05

Oxcarbazepine
Tablets, USP

150 mg

PHARMACIST: DISPENSE THE ACCOMPANYING
MEDICATION GUIDE TO EACH PATIENT.

Rx only 500 Tablets

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PRINCIPAL DISPLAY PANEL — 300 mg Tablet Bottle Label

NDC 60429-062-05

Oxcarbazepine
Tablets, USP

300 mg

PHARMACIST: DISPENSE THE ACCOMPANYING
MEDICATION GUIDE TO EACH PATIENT.

Rx only 500 Tablets

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PRINCIPAL DISPLAY PANEL — 600 mg Tablet Bottle Label

NDC 60429-063-05

Oxcarbazepine
Tablets, USP

600 mg

PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT.

500 Tablets

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OXCARBAZEPINE oxcarbazepine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-063(NDC:51991-294)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXCARBAZEPINE (OXCARBAZEPINE) OXCARBAZEPINE 600 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (120 .MU.M)
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FD&C YELLOW NO. 5
FD&C BLUE NO. 2
POLYVINYL ALCOHOL, UNSPECIFIED
ALUMINUM OXIDE
LECITHIN, SOYBEAN
TALC
Product Characteristics
Color brown (Beige) Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code B294
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-063-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60429-063-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078069 01/11/2008
OXCARBAZEPINE oxcarbazepine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-061(NDC:51991-292)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXCARBAZEPINE (OXCARBAZEPINE) OXCARBAZEPINE 150 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (120 .MU.M)
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FD&C YELLOW NO. 5
FD&C BLUE NO. 2
POLYVINYL ALCOHOL, UNSPECIFIED
ALUMINUM OXIDE
LECITHIN, SOYBEAN
TALC
Product Characteristics
Color brown (Beige) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code B292
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-061-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60429-061-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078069 01/11/2008
OXCARBAZEPINE oxcarbazepine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-062(NDC:51991-293)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXCARBAZEPINE (OXCARBAZEPINE) OXCARBAZEPINE 300 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (120 .MU.M)
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FD&C YELLOW NO. 5
FD&C BLUE NO. 2
POLYVINYL ALCOHOL, UNSPECIFIED
ALUMINUM OXIDE
LECITHIN, SOYBEAN
TALC
Product Characteristics
Color brown (Beige) Score 2 pieces
Shape OVAL Size 15mm
Flavor Imprint Code B293
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-062-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60429-062-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:60429-062-18 180 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078069 01/11/2008
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (60429-061), repack (60429-061), relabel (60429-062), repack (60429-062), relabel (60429-063), repack (60429-063)

Revised: 06/2021 Golden State Medical Supply, Inc.

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